BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET 360 ULTRA 1.5 MM X 2 CM

    MDR report key: 3192418 · Received June 27, 2013

    Report

    Report Number
    3008853977-2013-00206
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DEVICE ANALYSIS REVEALED THAT THE DELIVERY WIRE WAS BENT AT 24 AND 30 CM FROM THE PROXIMAL END. THE PROXIMAL, MIDDLE AND DISTAL PART OF THE MAIN COIL WERE COMPLETELY STRETCHED. IN ADDITION, THE COIL WAS OBSERVED TO BE BROKEN AS THE DISTAL TIP OF THE COIL WAS NOT PRESENT. INFORMATION AVAILABLE INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION POST UNPACKING AND PREPARATION AND CONTINUOUS FLUSH WAS MAINTAINED; HOWEVER, RESISTANCE WAS EXPERIENCED WHEN THE COIL WAS ADVANCED FROM THE INTRODUCER SHEATH INTO THE MICROCATHETER AND RESISTANCE WAS ALSO EXPERIENCED WHEN RETRACTING THE COIL BACK INTO THE INTRODUCER SHEATH. BASED ON THE INFORMATION AVAILABLE, IT IS PROBABLE THAT THE DAMAGE TO THE DELIVERY WIRE OCCURRED DURING HANDLING AS IT WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. HOWEVER, IT IS PROBABLE THAT DAMAGES TO THE MAIN COIL OCCURRED DURING ADVANCEMENT/RETRACTION OF THE COIL FROM/TO THE INTRODUCER SHEATH WHILE BEING ADVANCED INTO THE MICROCATHETER LIMITING ITS PERFORMANCE. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT WILL BE ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE DEVICE REVEALED THAT THE COIL WAS BROKEN AS THE DISTAL TIP OF THE COIL WAS NOT PRESENT.

    Description of Event or Problem · 1

    ANALYSIS OF THE DEVICE REVEALED THAT THE COIL WAS BROKEN AS THE DISTAL TIP OF THE COIL WAS NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292715 TARGET 360 ULTRA 1.5 MM X 2 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15603418

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR SL-10 (STRYKER)